Olympus Corporation of the Americas: Medical Device Recall in 2024 - (Recall #: Z-0935-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

EZDilate Fixed Wire Balloon 11-12-13. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1380

Product Classification:

Class II

Date Initiated: November 10, 2023

Date Posted: February 7, 2024

Recall Number: Z-0935-2024

Event ID: 93508

Reason for Recall:

Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.

Status: Ongoing

Product Quantity: 1008 units

Code Information:

UDI-DI: 00821925033184 Lot Numbers: 369624, 377715

Distribution Pattern:

Nationwide. Foreign: AU BR BR CA DE HK IN JP SG

Voluntary or Mandated:

Voluntary: Firm initiated